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Completed

NCT Number: NCT01504815

Adaptive Radiation Treatment for Head and Neck Cancer

This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gustave Roussy Cancer Institute, Villejuif, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • biopsy-confirmed squamous cell carcinoma of the oropharynx, oral cavity or hypopharynx
  • stage III/IV, T3-4, Nx M0
  • < 70 yrs
  • glomerular filtration rate (GFR) >60
  • WHO 0-1
  • no previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
  • adequate bone marrow function, adequate hepatic function,informed consent
  • >18 years

Exclusion criteria

  • expected failure from follow-up
  • previous malignancies except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
  • expected inability to complete either one of the treatment arms
  • pregnancy or lactation
  • patients (m/f) with reproductive potential not implementing adequate contraceptive measures
  • prior surgery, radiotherapy or chemotherapy for this tumor
  • contraindications or serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or are likely to interfere with the study assessments
  • known active symptomatic fungal, bacterial and/or viral infections including HIV
  • concomitant (or with 4 weeks before randomisation) administration of any other experimental drug
  • concurrent treatment with any other anti-cancer therapy
  • prior treatment with one or more of the active compounds

Treatment and study plan

Cisplatinum

Drug

i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy

Conventional radiotherapy

Radiation

conventional radiotherapy, 70Gy in 7 weeks

Adaptive Radiotherapy

Radiation

adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Primary outcomes

  1. locoregional recurrence-free survival

    Time frame: 2 years

  2. number of patients with grade 3 toxicity or more

    Time frame: 2 years

Secondary outcomes

  1. Quality of Life assessment

    Time frame: 2 years

  2. swallowing preservation

    Time frame: 1 year

    Tube feeding dependency at one year

  3. progression free survival

    Time frame: 2 years

  4. overall survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • European Union
  • Gustave Roussy, Cancer Campus, Grand Paris
  • Institut Catala de Salut
  • Karolinska Institutet
  • Maastricht Radiation Oncology
  • The Christie NHS Foundation Trust
  • UMC Utrecht

Registry information

Official study title

Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

Acronym: ARTFORCE

Important dates

Study start
2012
Primary completion
2021
Study completion
2024
First posted
Jan 5, 2012
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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